NZ621752B2 - Systems and methods to increase rigidity and snag-resistance of catheter tip - Google Patents

Systems and methods to increase rigidity and snag-resistance of catheter tip Download PDF

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Publication number
NZ621752B2
NZ621752B2 NZ621752A NZ62175212A NZ621752B2 NZ 621752 B2 NZ621752 B2 NZ 621752B2 NZ 621752 A NZ621752 A NZ 621752A NZ 62175212 A NZ62175212 A NZ 62175212A NZ 621752 B2 NZ621752 B2 NZ 621752B2
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NZ
New Zealand
Prior art keywords
catheter
body member
infusion system
tubular body
hole
Prior art date
Application number
NZ621752A
Other versions
NZ621752A (en
Inventor
Siddarth K Shevgoor
Original Assignee
Becton Dickinson And Company
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Publication date
Priority claimed from US13/223,178 external-priority patent/US9402975B2/en
Application filed by Becton Dickinson And Company filed Critical Becton Dickinson And Company
Publication of NZ621752A publication Critical patent/NZ621752A/en
Publication of NZ621752B2 publication Critical patent/NZ621752B2/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M2025/0073Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • A61M25/0015Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008Strength or flexibility characteristics of the catheter tip
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining

Abstract

venous catheter having a catheter tip comprising recessed (248) diffusion holes (250,251) for increasing the snag-resistance of the venous catheter. Also disclosed are systems and methods for providing axial ridges (266) interposed between diffusion holes for increasing the rigidity of the vented catheter tip. By having the apertures within such portions recessed from the outer surface of the catheter tip snag-resistance is enhanced. catheter tip. By having the apertures within such portions recessed from the outer surface of the catheter tip snag-resistance is enhanced.

Description

SYSTEMS AND METHODS TO INCREASE RIGIDITY AND SNAG—RESISTANCE OF CATHETER TIP BACKGROUND OF THE INVENTION The present invention relates generally to vascular infusion s and components, including catheter lies and devices used with catheter assemblies. In particular, the present invention relates to systems and methods for increasing the rigidity and snag- resistance of a catheter tip of a vascular infusion system having catheter hole arrays to provide enhanced infusion flow rates, lower system pressures, and reduced catheter exit jet velocities. Additionally, the present invention relates to ing the overall rigidity of a thin-walled structure.
Vascular access devices are used for communicating fluid with the anatomy of a patient. For e, vascular access devices, such as catheters, are ly used for infusing fluid, such as saline on, various medicaments, and/or total parenteral nutrition, into a patient, withdrawing blood from a patient, and/or monitoring various parameters of the patient’s vascular system.
A variety of clinical circumstances, including massive trauma, major surgical procedures, massive burns, and certain e states, such as pancreatitis and diabetic ketoacidosis, can produce nd circulatory volume ion. This depletion can be caused either from actual blood loss or from internal fluid imbalance. In these clinical settings, it is frequently necessary to infuse blood and/or other fluid rapidly into a patient to avert serious COHSCqUCIlCOS.
Additionally, the y to inject large quantities of fluid in a rapid manner may be desirable for certain other medical and diagnostic procedures. For example, some diagnostic imaging procedures utilize contrast media enhancement to improve lesion conspicuity in an effort to increase early stic yield. These procedures necessitate Viscous contrast media be injected by a specialized “power injector” pump intravenously at very high flow rates, which establishes a contrast bolus or small plug of contrast media in the bloodstream of the patient which results in enhanced image quality.
Power ion procedures generate high pressures within the infusion system, thereby requiring specialized vascular access devices, extension sets, media transfer sets, pump syringes, and bulk or led st media syringes. As the concentration (and thereby ity) and infusion rate of the contrast media are sed, bolus density also increases resulting in better image quality Via computed tomography (CT) attenuation. Therefore, a —Page 1- current trend in healthcare is to increase the bolus density of the contrast media by increasing both the concentration of the st media and the rate at which the media is infused into the patient, all ofwhich ultimately drives system pressure ements higher.
Intravenous infusion rates may be defined as either routine, generally up to 999 cubic centimeters per hour (cc/hr), or rapid, generally between about 999 cc/hr and 90,000 cc/hr (1.5 liters per minute) or higher. For some stic procedures utilizing viscous contrast media, an injection rate of about 1 to 10 ml/second is needed to ensure sufficient bolus concentration. Power ions of viscous media at this injection rate produce significant back pressure within the infusion system that commonly s in a failure of the infusion system components.
Traditionally, rapid infusion therapy entails the use of an intravenous catheter attached to a peristaltic pump and a fluid source. A patient is infused as a tip portion of the catheter is inserted into the vasculature of a patient and the pump forces a fluid through the catheter and into the patient’s vein. Current rapid infusion therapies e a catheter and catheter tip with geometries cal to those used with traditional, routine infusion rates. These ries include a tapering catheter tip such that the fluid is accelerated as the fluid moves through the catheter tip and exits into a patient’s ature. This acceleration of the infused fluid is undesirable for several reasons.
For example, the tapered catheter results in a greater backpressure for the remainder of the catheter assembly. This effect is undesirable due to the limitations of the pumping capacity of the infusion pump as well as the limited structural integrity of the components and ponents of the infilsion system. For e, if the backpressure becomes too great, the pump’s efficiency may decrease and n seals or connections within the infusion system may fail. Additionally, the fluid acceleration in the catheter tip results in a recoil force that may cause the catheter tip to shift within the patient’s vein thereby displacing the er and/or damaging the patient’s vein and/or injection site. Fluid acceleration also increases the jet velocity of the infusant at the tip of the catheter. In some procedures, the fluid jet may pierce the patient’s vein wall thereby leading to extravasation or ation.
Not only is this uncomfortable and l to the patient, but infiltration may also prevent the patient from receiving the needed therapy.
To overcome undesirable backpressures and increased acceleration of d fluids, some intravascular systems include arrays of diffuser holes provided in and around the tip portion of the intravenous catheter. Examples of arrays of diffuser holes and diffuser hole geometries are ed in US. Patent Application Nos. 12/427,633 and 13/022,501, each ofwhich are -Page 2— incorporated herein by reference.
In general, diffuser holes increase the surface area of the catheter tip opening thereby decreasing fluid pressure at the catheter tip opening. However, addition of diffuser holes at or near the tip of a catheter also reduces the buckling resistance of the catheter thereby making the er tip more susceptible to crushing during insertion. As a result, the addition of diffuser holes may result in failed catheterization and physical pain to the t. r, addition of diffuser holes provides the er with a non-continuous outer surface that may snag or catch on the opening of the patient’s skin and/or vein through which the catheter is inserted. This too may result in failed catheterization, physical pain and/or physical damage to the patient.
Thus, while methods and systems currently exist to reduce exit velocity of an infusant during rapid infusion procedures, challenges still exist. Accordingly, it would be an improvement in the art to augment or even replace current techniques with other techniques.
BRIEF SUMMARY OF THE INVENTION The systems and methods of the present disclosure have been developed in response to problems and needs in the art that have not yet been fully resolved by currently available infusion systems and methods. Thus, these systems and methods are developed to provide for safer and more efficient rapid infiision procedures.
One aspect of the t invention provides an improved vascular access device for use in combination with a vascular infusion system capable of rapidly delivering an infusant to the vascular system of a patient. The vascular access device generally es an intravenous catheter red to access the vascular system of a patient. The enous catheter is coupled to the ar on system via a section of intravenous g. The material of the intravenous catheter may include a polymer or metallic maten'al compatible with infusion procedures.
In some embodiments, a tip n of the intravenous catheter is d to include a plurality of diffusion holes. The tip portion generally comprises a tapered , wherein the outer and inner surface of the tip taper towards the distal end of the catheter. The d outer surface es a smooth transition between the narrow diameter of the catheter tip opening and the larger diameter of the catheter tubing. Thus, as the tip of the catheter is introduced into the vein of a patient, the tapered outer surface facilitates easy insertion of the catheter through the access hole. The tapered inner surface is lly provided to tightly contact the outer surface of an introduce-r needle housed within the lumen of the catheter.
The introducer needle is provided to create an opening into the vein ofpatient through which -Page 3- the catheter tip is inserted. The tapered inner surface ensures a tight seal between the inner surface of the catheter and the outer e of the needle. Following placement of the catheter, the introducer needle is removed.
In some implementations, a eral er is provided comprising a catheter body having an outer surface, a proximal end, a distal end, a lumen extending between the proximal and distal ends, and a distal lumen opening, the catheter further including a recess formed in the outer surface of the catheter body. In some implementations, a diffusion hole is further positioned within the recess through a wall thickness of the catheter body. As such, the recessed on of the diffusion hole is removed fiom directly contacting the skin or other tissues of the patient during insertion of the catheter. Accordingly, the diffusion hole is prevented from snagging the skin or tissues of the t.
In some implementations, a method for manufacturing a snag-resistant, vented er is provided, wherein the method includes the steps of providing a catheter body having an outer surface, a proximal end, a distal end, a lumen extending between the proximal and distal ends, and a lumen opening. The method further includes the steps of providing a recess in the outer surface of the er body, and further providing a diffusion hole in the recess through a wall thickness of the catheter body. As such, the recessed location of the diffusion hole is removed from directly contacting the skin or other s of the patient during insertion of the catheter. Accordingly, the diffusion hole is prevented from snagging the skin or tissues of the patient.
Further, in some implementations, a peripheral er is provided comprising a catheter body having a predetermined wall thickness, the er body member having a proximal end, a distal end, a lumen extending n the proximal and distal ends, and a distal lumen opening, the catheter body further having a truncated length to access a peripheral vein of a patient. In some implementations, the peripheral er further comprises a recess formed in the outer surface of the catheter body, wherein a hole is provided within the recess through the predetermined wall thickness and in communication with the lumen. As such, the ed location of the diffusion hole is removed from ly contacting the skin or other tissues of the t during insertion of the catheter. Accordingly, the diffusion hole is prevented from snagging the skin or tissues of the patient.
The present invention fiuther includes methods for manufacturing an intravenous catheter for diffusing an infusant. Some methods include the steps of providing an intravenous catheter and g a plurality of red holes through the wall thickness of the intravenous catheter. Some methods ofthe present invention further include using a laser drill to provide —Page 4- the various staggered holes. Still further, some methods of the present invention include extrusion and co—extrusion processes for providing the catheter body and various other features discussed in detail below.
BRIEF PTION OF THE SEVERAL VIEWS OF THE DRAWINGS In order that the manner in which the above-recited and other es and advantages of the invention are obtained will be readily understood, a more particular description of the invention briefly described above will be rendered by reference to c embodiments thereof'which are illustrated in the appended drawings. These gs depict only typical embodiments of the invention and are not therefore to be considered to limit the scope of the invention.
Figure 1 is a perspective view of an infusion system in accordance with a representative ment ofthe present invention.
Figure 2 is a detailed perspective view of a catheter in accordance with a representative embodiment ofthe present invention.
Figure 3 is a perspective view of a catheter tip in accordance with a representative embodiment ofthe present invention.
Figure 4 is a section side View ofthe catheter tip in accordance with a representative embodiment of the t invention.
Figure 5 is a cross-section side View of a catheter tip during catheterization in accordance with a entative embodiment ofthe present invention.
Figure 6A is a cross-section end View of a catheter tip during catheterization in accordance with a representative embodiment ofthe present invention.
Figure 6B is a cross-section end view of a catheter tip during eatheten'zation, the catheter tip incorporating a stiffening material in accordance with a representative embodiment of the present invention.
Figure 7 is a detailed cross-section end view of a catheter tip having a flow breaking feature in accordance with a representative ment of the present invention.
Figure 8 is a perspective view of a catheter tip in accordance with a entative embodiment of the present ion.
DETAILED DESCRIPTION OF THE INVENTION Embodiments of the present invention will be best understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. It will be y understood that the components of the t invention, as generally described and illustrated in the figures herein, could be arranged and ed in a wide variety of different -Page 5- configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as d, but is merely representative of presently preferred embodiments ofthe invention.
The systems and methods of the present invention are generally designed for use in combination with a vascular infusion system capable of y delivering an nt to the vascular system of a patient. Referring now to Figure l, a vascular on system 100 is shown, in accordance with a representative embodiment of the present invention. on systems of this type are ly configured to operate at internal pressures up to 2000 psi. Many systems operate in the range of 75 to 2000 psi, while specific devices of this type operate at 100, 200, and 300 psi. The vascular infusion system 100 comprises a vascular access device 112 coupled to an injector pump 120 via a coiled extension set 130. In some embodiments, the infusion system 100 further comprises a safety device 140 positioned between the vascular access device 112 and the or pump 120. In some ments, a safety device 140 is provided to automatically occlude the fluid path of the infusion system 100, thereby preventing excessive pressure buildup in downstream infusion components.
An injector pump 120 generally comprises a fluid pumping apparatus configured to rapidly r an infusant, such as blood, medicaments, and CT scan contrast agents to a patient’s vascular system. Desirable nts may also include various fluids often of high viscosity as required for medical and diagnostic procedures. In some embodiments, the injector pump 120 comprises a power injector capable of delivering an infusant to a patient at flow rates from about 10 mL/hour up to about 1200 mL/minute. In some embodiments, a high on flow rate is desirable for medical procedures which require enhanced bolus density of an nt in a patient’s vascular system. For example, a trend in stic imaging procedures is to e contrast media enhancement, which requires more s st media to be pushed into a patient at a higher flow rate, thereby resulting in increased image quality. Thus, in some embodiments an injector pump 120 and a vascular access device 112 are selected to compatibly achieve a desired infusion flow rate.
A coiled extension set 130 generally comprises flexible or exible polymer tubing configured to deliver an infusant from the injector pump 120 to the vascular access device 112. The extension set 130 includes a first coupler 132 for connecting the extension set 130 to a downstream device 112 or 140. The extension set 130 also includes a second coupler 134 for connecting the extension set 130 to the injector pump 120. A coiled configuration of the extension set 130 generally prevents undesirable kinking or occlusion of the set 130 during infusion procedures. However, one of skill in the art will appreciate that the extension —Page 6- set 130 may include any configuration e of efficiently delivering an infusant from an injector pump 120 to the patient via a vascular access device 112. In some embodiments, the extension set 130 is coupled between a syringe and a vascular access device whereby an infusant is manually injected into a patient. In other embodiments, the infusion system comprises only a syringe and a vascular access device, in accordance with the t ion.
The vascular access device 1 12 generally comprises a peripheral intravenous catheter I 14.
A peripheral intravenous catheter 114 in accordance with the present invention generally comprises a short or truncated catheter ly 13mm to 52mm) that is inserted into a small peripheral vein. Such catheters generally comprise a diameter of approximately a 14 gauge catheter or smaller. Peripheral intravenous catheters 114 are typically ed for temporary placement. The short length of the catheter 114 facilitates convenient ent of the catheter but makes them prone to premature dislodging from the vein due to nt of the patient and/or recoil forces experienced during infusion procedures. Furthermore, unlike midlirte or central eral ers, peripheral intravenous ers 114 in accordance with the present invention comprise a tapered catheter tip 146 to accommodate use with an introducer needle (not shown) designed to aid in insertion of the catheter 114.
An introducer needle is typically inserted through the catheter 114 such that a tip of the needle extends beyond the tapered tip 146. The tapered geometry of the tapered tip 146 conforms tightly to the outer surface of the introducer needle. Both the outer surface and the inner surface of the tip 146 are tapered towards the distal end of the catheter 114. The outer surface of the tip 146 is tapered to provide a smooth transition from the smaller profile of the introducer needle to the larger profile of the catheter outer diameter. ion of the introducer needle into the vein of the patient provides an opening into the vein through which the tapered tip 146 of the catheter 114 is inserted. The tapered outer surface of the tip 146 enables easy insertion of the catheter 114 into the opening. Once the peripheral intravenous catheter 114 is inserted into the vein of the patient, the introducer needle (not shown) is removed from the lumen ofthe catheter 114 to permit infusion via the catheter 114.
A d infusant is typically delivered to the catheter 114 via a section of enous tubing 1 16 coupled to the catheter 114. In some embodiments, a y-adapter 118 is d to an end ofthe tubing 116 Opposite the catheter 114, enabling the vascular access device 112 to be coupled to the remainder of the vascular infusion system 100. One of skill in the art will appreciate the possible variations and specific features of available vascular access devices 1 12, as are commonly used in the medical and ch professions. For example, in some -Page 7— rnents a catheter 114 in accordance with the present invention may include additional access sites, clamps, parallel intravenous lines, valves, couplers, introducer needles, coatings, and/or materials as desired to fit a specific application.
Referring now to Figure 2, a catheter 214 is shown in accordance with a representative embodiment of the present invention. Catheter 214 generally comprises a catheter adapter 218 configured to house a r body member 220. Catheter adapter 218 further includes an inlet port 230 that is coupled to a section of intravenous tubing 216. The section of intravenous tubing 216 is fiirther coupled to am infusion components, as shown and described in tion with Figure 1, above.
The er adapter 218 facilitates delivery of an nt within the intravenous tubing 216 to a patient Via the tubular body member 220. An inner lumen of the catheter adapter 218 is in fluid communication with both an inner lumen of the intravenous tubing 216 and an inner lumen of the tubular body member 220. In some ments, catheter adapter 218 further comprises an access port 222. The access port 222 is generally provided to permit direct access to the inner lumen of the catheter adapter 218. In some embodiments, the access port 222 is accessed via a needle and a syringe to deliver an infusant to a patient via the tubular body member 220. In other embodiments, an introducer needle or guide wire is inserted into the access port 222 and advanced through the inner lumen of the tubular body member 220. In some embodiments, a tip portion of the introducer needle or guide wire (not shown) extends beyond a tip n 240 of the tubular body member 220. As such, the tip portion of the introducer needle or guide wire may provide an opening into the vascular system of a patient into which the tubular body member 220 is inserted. ing placement of the tubular body member 220 into the vein of the patient, the introducer needle or guide wire is removed from the access port 222 thereby establishing fluid communication between the tubular body member 220, the catheter adapter 218 and the enous tubing 216.
In some embodiments, the tubular body member 220 comprises an enous catheter.
The intravenous catheter 220 generally comprises a flexible or semi—flexible biocompatible material, as ly used in the art. In some embodiments, the intravenous catheter 220 ses a polymer material, such as polypropylene, polystyrene, polyvinylchloride, polytetrafluoroethylene, and the like. In other ments, the intravenous catheter 220 comprises a ic material, such as surgical steel, titanium, cobalt steel, and the like.
The tubular body member 220 may comprise any length, where the length is selected based on the intended application of the catheter 214. For some applications, the tubular body member 220 is inserted into a peripheral vein ofthe patient. In other applications, the tubular —Page 8- body member 220 is inserted into a central vein of the patient. In some embodiments, the tip portion 240 of the tubular body member 220 is modified to include a recess 248 formed in the wall thickness of the tubular body member 220, as shown in Figures 2 and 3.
With continued reference to Figures 2 and 3, recess 248 generally comprises a small concavity defined by adjacent lls or chamfered surfaces 249. In some embodiments recess 248 further comprises a diffusion hole 250 to facilitate rapid infusion applications.
Diffusion hole 250 is generally provided to divert fluid from the main l of flow through the inner lumen of the tubular body member 220. As such, ion hole 250 effectually slow the jet of infusant which issues from the catheter tip 240 during rapid infilsion procedures. Additionally, diffusion hole 250 increases the accumulative area of the catheter tip opening 242 to relieve the overall pressure in the vascular infusion system 100.
In some embodiments, diffiision hole 250 ses one or more side holes which meet the requirements of International Standard ISO 10555-2, section 4.4.3.
In some ments, tubular body member 220 r comprises a plurality of recesses, as‘ shown in Figure 4. For example, in some embodiments tubular body member 220 comprises a second recess 258 positioned te recess 248. Second recess 258 further comprises a second diffusion hole 251 positioned opposite diffusion hole 250. In some embodiments, a plurality of recesses and diffusion holes are provided in adjacent, annular rings along the length of tubular body member 220. In other embodiments, the ity of recess and diffusion holes are provided in a staggered pattern of nt, annular rings along the length of tubular body member 220. As such, an upstream recess and diffusion hole is ned with an adjacent, downstream recess and diffusion hole. es 248 and 258 are generally provided by manufacturing methods known in the art.
For example, in some embodiments recesses 248 and 258 are provided via an extrusion process. In other embodiments, recesses 248 and 258 are provided via an etching process, such as laser etching. Further, diffusion holes 250 and 251 are lly provided by manufacturing methods known in the art. For example, in some embodiments the plurality of ion holes 250 and 251 are provided with a laser drill.
In some embodiments, recesses 248 and 258 are rically positioned on tubular body member 220 so as to prevent catheter tip 240 from being displaced due to lateral forces causes by an infusant exiting diffusion holes 250 and 251. For example, in some embodiments a tubular body member 220 is provided having three recesses, wherein each recess comprises a diffusion hole radially spaced approximately 120° from an nt diffiision hole. In further example, some embodiments comprise a tubular body member 220 -Page 9— having greater than three recesses and greater than three diffusion holes. atively, in some embodiments tubular body member 220 is modified to e a plurality of axial ridges 266 formed on the outer e of tubular body member 220 by extrusion or another heat forming method. Diffusion holes 250 and 251 may be placed between axial ridges 266, as shown. During catheterization (i.e.: insertion of tubular body 220 into the vascular system of a patient), axial ridges 266 lift the skin and other tissues of the patient over diffusion holes 250 and 251 thereby preventing tissue from getting snagged in the diffusion holes, as discussed below.
In some embodiments, diffusion holes 250 and 251 are formed through the catheter wall 260 such that an inner surface 252 of each hole is ed at an angle 262 that is oblique to an irmer surface 272 of the catheter lumen 270. In some ments, angle 262 is between about 15° to about 75°. In other embodiments, angle 262 is approximately 45°. r, in some embodiments angle 262 is approximately 90° relative to inner surface 252.
In some embodiments, the bore angle 262 further affects the positioning of the catheter within the vein of t. For example, when inserted into a vein the venous catheter generally extends through the skin and into the vein at approximately 30°. As such, the tip of the venous catheter commonly contacts or rests against the inner wall of the vein opposite the insertion site of the catheter. As fluid flow increases, high jet velocity from the catheter tip is exerted directly on the inner wall of the vein. However, when the tip of the venous er is modified to include diffusion holes, the diverted infusant that issues from the diffusion holes pushes the catheter tip away from the vein wall resulting in a centralized position of the er tip within the vein. Thus, the jet velocity from the tip is directed into the fluid stream of the vein rather than into the vein wall. Accordingly, in some embodiments the bore angle 262 of diffusion holes 250 and 251 is selected to achieve optimal centralized positioning of catheter tip 240 within the vasculature of the t during infusion procedures.
Referring now to Figure 5, a distal end portion 242 of venous catheter 214 is shown, in accordance with a representative embodiment of the present invention. As previously sed, in some embodiments an outer e of catheter tip 240 is tapered so as to provide a gradual transition from catheter opening 242 of tip 240 to the diameter of tubular body 220. Further, in some ments the outer surface of catheter tip 240 is tapered so as to provide a gradual transition fiom the outer er of an introducer needle 300 to the diameter oftubular body 220, as shown.
In some embodiments, venous catheter 214 comprises an over—the—needle catheter. Thus, in some embodiments an opening 320 is provided within the skin 302 or other tissue of —Page 10— the patient by an introducer needle 300 housed within the catheter lumen 270. In some embodiments, a tip 310 of the introducer needle 300 is positioned external to the catheter lumen 270 so as to provide an exposed cutting surface by which to e an opening 320 into the ature of the patient. Upon advancing the venous catheter into the patient, the tapered configuration of tubular body 220 permits easy passage of the catheter’s tip 240 in opening 320.
As shown, axial ridges 266 lift the skin 302 or other tissues of the patient away from diffusion holes 250 and 251 during catheterization. Alternatively, recesses 248 and 258 position diffusion holes 250 and 251 away from opening 320 thereby ting undesirable contact or snagging between the ion holes and opening 320. Thus, in some embodiments axial ridges 266 and/or recesses 248 and 258 increase the esistance of catheter tip 240, as shown in Figure 6A.
In some embodiments, the inclusion of diffusion holes at or near the tip of a short catheter may result in a reduction of buckling ance for the catheter thereby making the catheter more susceptible to ng during catheterization. Accordingly, in some embodiments axial ridges 266 further increase the bending and buckling stiffness of catheter tip 240, thereby minimizing the risks of catheter tip crushing or buckling during insertion. One having ordinary skill in the art will ore iate and recognize that the stiffening effect of axial ridges 266 may be accomplished by any number of structural ations wherein the thickness and/or rigidity of the catheter wall 260 between diffusion holes 250 and 251 is increased to withstand compression and/or sheer forces during insertion.
For example, in some embodiments the rigidity of the catheter wall 260 oned n diffusion holes 250 and 251 is sed by the addition of a stiffening material 290, as shown in Figure 6B. In some embodiments, ning material comprises a rigid or semi-rigid radiopaque material, such as a wire or an extruded filler material which may include a chemical salt of bismuth or barium, or an element such as platinum or tungsten. In some embodiments stiffening material 290 comprises barium sulfate. In other embodiments, stiffening material 290 comprises a polymer material having an increased density as compared to the remaining polymer material of the venous catheter 214. In some embodiments, venous catheter 214 and stiffening material 290 are coextruded, wherein stiffening material 290 is embedded within the wall thickness of the tubular body member 220. In other embodiments, stiffening material 290 is applied directly to the external surface oftubular body member 220, thereby forming axial ridges 266.
—Page 11— Referring now to Figure 7, in some embodiments sidewalls 249 further comprise a flow breaking feature 280. A “flow breaking feature” refers to a e of the diffusion hole 250 and/or a physical feature adjacent to the ion hole 250 that substantially breaks up, thins, or slows a jet of infusant exiting the diffusion hole 250 so that the jet will lose speed more quickly Within the vein.
Figures 2-7 generally depict circular diffusion holes. However, in some embodiments one or more diffusion holes may be non—circular. For example, in some embodiments flow breaking feature 280 may include a flow disrupter, elongated diffusion hole geometries, and diffusion hole orientations such that the axis of flow of two or more diffusion holes collide.
In some embodiments, flow ng feature 280 is a flow ter comprising an inward projection that contacts the jet of infusant exiting diffusion hole 250. In other embodiments, flow breaking feature 280 is a flow disrupter including a pointed extension. r, in some embodiments feature 280 comprises a ity of inward projections. An “inward projection” refers to a n of a diffusion hole’s periphery which projects toward the inner n ofthe diffiision hole.
In some embodiments, a single diffusion hole includes more than one flow breaking features. Examples of flow breaking es are described herein, including at least inward projections, wedged extensions, an elongated diffusion hole ry, and diffiision hole axis orientations that result in collisions with other fluid jets. For example, in some embodiments, a diffusion hole includes an inward projection and has an axis orientation that collides with that of another hole. In addition, in some ments the diffusion hole further includes a wedged extension. In other embodiments, other combinations of flow breaking features are combined to provide a less harmful, more effective catheter diffusion hole and diffusion hole array configuration.
From the ing, it will be seen that one or more flow breaking features can be included on one or more catheter diffusion holes on a catheter tip. The flow breaking features can substantially break up, thin, or slow a jet of fluid exiting a diffusion hole so that the jet will lose speed more quickly within the vein and cause less damage to vessel walls. In particular, flow breaking features are particularly advantageous when used in rapid infusion therapy that uses highly nt velocities to rapidly introduce a bolus of fluid into a patient through the catheter tip. During these procedures, one or more flow breaking features of a diffusion hole can increase on patient comfort, decrease patient pain, allow for greater on velocities, and prevent vessel damage.
—Page 12- Referring now to Figure 8, in some ments recess 288 and axial ridges 296 are extended along the length of tubular body 220, thereby odating a plurality of recessed diffusion holes 298. Accordingly, the sum of the exiting infnsant jets from recessed diffusion holes 298 will produce a fluid infusion with less impact energy and which poses a lesser risk to the patient’s vessel walls. In some embodiments, recess 288 comprises a near recess thereby providing a non-linear alignment of recessed diffusion holes 298.
For example, in some embodiments recess 288 comprises a helical recess, wherein recess 288 circumscribes the outer surface of tubular member 220 in a helical fashion. In other embodiments, recess 288 comprises a plurality of longitudinal recesses, wherein a portion of each longitudinal recess is interested with a ridge thereby dividing each longitudinal recess into two or more ns.
The present invention may be embodied in other specific forms without departing from its structures, methods, or other essential teristics as broadly described herein and claimed hereinafter. The described embodiments are to be considered in all respects only as illustrative, and not. restrictive. The scope of the invention is, therefore, ted by the appended claims, rather than by the ing description- All changes that come within the meaning and range of equivalency ofthe claims are to be embraced within their scope.
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Claims (14)

  1. l. A vascular infusion system, comprising: a vascular access device red to be coupled to an injector pump for injecting an infusant into the vasculature of a patient, the vascular access device sing a er through which the infusant is injected, the catheter comprising a catheter adapter that couples to the injector pump and a r body member that s from the catheter adapter, the tubular body member having an outer surface, a proximal end, a distal end, a lumen extending between the al and distal ends, a tapered tip at the distal end, and a distal lumen opening, the catheter adapter further including an introducer needle that is contained within the lumen and extends distally from the distal lumen opening of the tubular body member; characterized in that the tubular body member comprises: a recess formed in the outer surface, the recess sing ng sidewalls and a surface, the recess extending along the tapered tip of the tubular body member in a direction parallel to the length of the tubular body member; and at least one hole positioned in the recess, the hole being formed in the surface through a wall thickness of the r body member and in fluid communication with the lumen.
  2. 2. The vascular infusion system of claim 1, wherein the at least one hole comprises a ity of holes.
  3. 3. The vascular infusion system of claim 1, further comprising a plurality of recesses, wherein each of the recesses comprises at least one hole.
  4. 4. The vascular infusion system of claim 1, wherein the tapered tip is tapered from an outer diameter of the introducer needle to an outer diameter of the tubular body member.
  5. 5. The vascular infusion system of claim 4, further comprising a flow breaking feature positioned on one or both of the lls.
  6. 6. The vascular infusion system of claim 5, wherein the flow breaking feature includes a flow disrupter.
  7. 7. The vascular infusion system of claim 6, wherein the flow disrupter is an inward projection.
  8. 8. The vascular infusion system of claim 1, wherein a bore angle of the hole is oblique to an inner wall surface of the lumen.
  9. 9. The ar infusion system of claim I, wherein the tubular body member further comprises a stiffening material embedded within the wall thickness of the tubular body member.
  10. 10. The vascular infusion system of claim 9, wherein the stiffening material comprises a plurality of strips of the stiffening material that are spaced within and extend along the length of the tapered tip.
  11. 1 1. The vascular infusion system of claim 10, wherein the stiffening material ses a radiopaque material.
  12. 12. The ar infusion system of claim I, further comprising a flow breaking e that is positioned nt to the hole.
  13. 13. The vascular infusion system of claim 12, wherein the flow breaking feature comprises a ar protrusion that extends around the hole.
  14. 14. The vascular infusion system of claim 3, wherein the plurality of recesses comprise two recesses positioned on opposite sides of the tubular body member, and the at least one hole in one recess and the at least one hole in the other recess are symmetrically positioned such that when the infiisant is injected through the holes, the forces generated by the infusant leaving each hole are balanced. IS. The vascular infusion system of claim 1, wherein the catheter r includes an access port through which the lumen of the tubular body member is accessible.
NZ621752A 2011-08-31 2012-08-07 Systems and methods to increase rigidity and snag-resistance of catheter tip NZ621752B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US13/223,178 US9402975B2 (en) 2011-08-31 2011-08-31 Systems and methods to increase rigidity and snag-resistance of catheter tip
US13/223,178 2011-08-31
PCT/US2012/049859 WO2013032647A1 (en) 2011-08-31 2012-08-07 Systems and methods to increase rigidity and snag-resistance of catheter tip

Publications (2)

Publication Number Publication Date
NZ621752A NZ621752A (en) 2016-07-29
NZ621752B2 true NZ621752B2 (en) 2016-11-01

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